rejuvenair® system trial for copd with chronic bronchitis

Conditions: Chronic Bronchitis

Summary: chronic obstructive pulmonary disease (copd) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. chronic bronchitis (cb) is a common clinical phenotype within the umbrella of a copd diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. cb is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of copd, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

the rejuvenair® system is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. cryotherapy with the rejuvenair® system is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. this reversal of inflamed epithelium may also lessen systemic inflammation.

Eligibility criteria:
inclusion criteria * males and females ≥40 to ≤80 years of age * subject is able to read, understand, and sign a written informed consent in order to participate in the study * subject has a diagnosis of chronic bronchitis (cb) and/or chronic obstructive pulmonary disease (copd) for a minimum of two years. (chronic bronchitis is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded) * subject is classified as having a moderate or severe (gold 2/3) airflow obstruction defined by a post-bronchodilator of ≥30% fev1 to \<80% predicted with a baseline fev1/fvc of \<0.70 * subject has a baseline sgrq of ≥50 * subject demonstrates daily cough and significant mucus. * subject is being treated according to current medically accepted treatment guidelines for chronic bronchitis for minimum of 3 months prior to enrollment into the study. subject agrees to continue maintenance pulmonary/copd medications (gold standard medications recommended) for the duration of the study * non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study * subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over subjects may undergo two additional bronchoscopic procedures, if they agree to treatment), per hospital guidelines * subject demonstrates ability and willingness to use a daily ediary exclusion criteria * subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy * current diagnosis of asthma * subject has alpha-1 antitrypsin deficiency as defined by blood level \<59 mg/dl * subject has other origins of respiratory disease aside from chronic bronchitis and copd * subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician * subject has untreatable or life threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure * subject has bullous emphysema characterized as large bullae \>30 millimeters on hrct; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis * subject has clinically significant bronchiectasis * subject has had a solid transplant procedure * subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery * subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies * subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, coumadin, lmwh, heparin, clopidrogel (or equal) * subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux * subject is pregnant, nursing, or planning to get pregnant during study duration * subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study * subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation * subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)